Company Overview
Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company pioneering the development of innovative treatments for acute cannabis-induced toxicity. As the cannabis industry continues to expand across the United States, the company is poised to address a critical unmet medical need - the lack of approved therapies to rapidly reverse the serious and life-threatening consequences of unintentional cannabis poisoning, particularly in vulnerable pediatric populations.
Anebulo Pharmaceuticals, Inc. was founded on April 23, 2020 as a Delaware corporation, with its principal operations located in Lakeway, Texas. The company's primary focus is on developing treatments for cannabis-induced toxicity, including unintentional cannabis poisoning in children, acute cannabinoid intoxication (ACI) in adults, and other acute cannabis-induced conditions. Prior to its initial public offering (IPO) in May 2021, Anebulo funded its operations through a private placement of series A convertible preferred stock and the issuance of two promissory notes to a related party.
Licensing Agreement and Lead Product Candidate
In May 2020, Anebulo secured a crucial licensing agreement with Vernalis Development Limited, obtaining rights to certain intellectual property, know-how, and clinical trial data. This agreement allows Anebulo to exploit licensed compounds and products to combat symptoms of ACI and substance addiction. The company's lead product candidate, selonabant, is a potent, small molecule cannabinoid receptor antagonist that has demonstrated the ability to rapidly block and reverse the central nervous system (CNS) effects of delta-9-tetrahydrocannabinol (THC), the primary psychoactive compound in cannabis.
Clinical Progress
In a recently completed Phase 2 proof-of-concept study, oral selonabant was shown to effectively mitigate the CNS effects of THC in 134 healthy adult volunteers. Importantly, these results have paved the way for the development of an intravenous (IV) formulation of selonabant, which Anebulo believes could provide a much-needed targeted therapy for rapidly reversing acute cannabis toxicity in children.
Recognizing the growing prevalence of unintentional cannabis poisoning in pediatric populations, particularly as more states legalize cannabis for medical and recreational use, Anebulo has made the development of its IV selonabant formulation its top priority. The company recently met with the U.S. Food and Drug Administration (FDA) to discuss its plans for clinical testing of the IV formulation, and the agency acknowledged the significant unmet need in this area and expressed a willingness to collaborate closely with Anebulo to efficiently advance the program.
Research Grant and Future Plans
Anebulo's progress has been bolstered by a $1.9 million grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support the development of its IV selonabant formulation. With this funding and the FDA's support, the company expects to initiate a Phase 1 single ascending dose study in healthy adults in the first half of 2025, bringing it one step closer to potentially providing a much-needed treatment option for children suffering from the serious consequences of acute cannabis exposure.
Intellectual Property
The company's proprietary position in the treatment of cannabis toxicity is further strengthened by its exclusive, royalty-bearing license agreement with Vernalis Development Limited, which provides Anebulo with rights to the selonabant compound and associated intellectual property. Additionally, in October 2023, the United States Patent and Trademark Office issued Anebulo U.S. Patent No. 11.8M titled "Crystalline forms of a cannabinoid receptor type 1 (CB1) modulator and methods of use and preparation thereof". This patent describes crystalline forms of selonabant and methods of use to treat acute cannabinoid overdose, and is expected to provide patent protection through 2042.
Market Opportunity
Anebulo's focus on developing solutions for acute cannabis-induced toxicity comes at a critical juncture, as the United States Department of Justice has announced plans to reclassify marijuana from a Schedule I to a Schedule III controlled substance. This shift is expected to lead to increased use of cannabis-containing products, potentially exacerbating the already growing problem of unintentional cannabis poisoning, particularly in children.
Financials
In December 2024, Anebulo bolstered its financial position by completing a $15 million private placement, providing the company with the resources to advance its IV selonabant program and other pipeline initiatives. As of December 31, 2024, Anebulo had cash and cash equivalents of $15 million, which, combined with access to funding under its Loan Agreement, is expected to enable the company to fund its current and planned operating expenses and capital expenditures through at least the second quarter of 2026.
For the most recent quarter (Q2 FY 2025), Anebulo reported no revenue, which is consistent with its status as a clinical-stage company. The net loss for the quarter was $2,463,030, with operating cash flow (OCF) and free cash flow (FCF) both at -$1,405,744. Research and development expenses for the three and six months ended December 31, 2024 were $1.22 million and $2.54 million, respectively, while general and administrative expenses for the same periods were $1.37 million and $2.46 million, respectively.
As of December 31, 2024, the company had an accumulated deficit of $70.1 million. The net loss for the three and six months ended December 31, 2024 was $2.46 million and $4.66 million, respectively. It's important to note that as a clinical-stage company, Anebulo has not generated any revenue since its inception and has incurred operating losses and negative cash flow as it has funded its research and development activities.
Liquidity
Anebulo's liquidity position remains strong, with a current ratio and quick ratio both at 48.18. The company reports no debt, resulting in a debt-to-equity ratio of 0. On February 10, 2025, Anebulo modified its Loan and Security Agreement to reduce the maximum loan advance to $3.0 million. As of February 14, 2025, there was no balance outstanding under the modified agreement, providing additional financial flexibility if needed.
Anebulo's unwavering focus on addressing the critical unmet need for effective treatments for acute cannabis-induced toxicity, coupled with its strong financial positioning and strategic partnerships, positions the company for continued success in the years ahead. As the cannabis industry continues to evolve, Anebulo remains dedicated to developing novel solutions that can make a meaningful difference in the lives of those affected by the serious consequences of unintentional cannabis exposure.
Challenges and Risks
It is important to note that as a clinical-stage company, Anebulo has faced several challenges since its inception. The company has not generated any revenue since being founded and has incurred operating losses and negative cash flow as it has funded its research and development activities. Additionally, Anebulo has had to navigate the complex regulatory landscape in order to advance the clinical development of selonabant.
Geographic Markets and Business Overview
As a small-cap company, Anebulo currently appears to operate primarily in the United States. The company does not provide specific information on performance by geographic markets. Anebulo's focus remains on developing selonabant as a potential treatment for cannabis-induced toxicity, with particular emphasis on its intravenous formulation for pediatric patients with cannabis-induced CNS depression.
The company's development efforts have included previous clinical trials that showed oral selonabant is rapidly absorbed, well-tolerated, and can lead to weight loss when repeatedly administered to obese subjects. This effect is consistent with central antagonism of the cannabinoid receptor type-1 (CB1), the primary target of agonists like THC.
In March 2023, Anebulo announced complete results from Part A and Part B of the Netherlands Trial, which involved a total of 134 subjects. Rather than proceeding directly with Phase 3 studies of oral selonabant in adults with ACI, the company is now prioritizing the advancement of the selonabant intravenous (IV) formulation for pediatric patients. This strategic decision is based on the potential for a faster timeline to approval relative to the adult oral product.
Recent Developments
Anebulo met with the FDA in December 2024 for a Pre-IND meeting to discuss the development of IV selonabant and the initial plan for clinical testing. The company plans to begin a Phase 1 single ascending dose study of IV selonabant in healthy adults in the first half of 2025. This progress, combined with the company's strong financial position and the support from the NIDA grant, positions Anebulo to continue advancing its innovative approach to addressing the growing concern of cannabis-induced toxicity.